Antacid Recalls Grow

New ranitidine recalls prompted by suspected product contamination with the probable human carcinogen N-Nitrosodimethylamine (NDMA) have been announced by four firms. The latest recalls were included in the January 29, 2020, US Food and Drug Administration (FDA) Enforcement Report. 

On December 11, 2019, RemedyRepack Inc. initiated a voluntary recall of 150-mg ranitidine tablets distributed in California and New York. The tablets were repackaged by RemedyRepack (original NDC 65162-0253-10, repackaged NDC 70518-1714-00) and were from lots J0376034-052319 (Exp. 5/20), J0406133-093019 (Exp. 10/20), J038005-082719 (Exp. 8/20), J0390280-072519 (Exp. 7/20), J0390277-072519 (Exp. 7/20), and J0349352-012519 (Exp. 1/20).

On December 20, 2019, Denton Pharma Inc. initiated a voluntary recall of ranitidine tablets that were repackaged by Northwind Pharmaceuticals and distributed throughout the United States. The recall includes the following products:

• 4-count bottles of 150-mg ranitidine tablets (NDC 70934-017-04) from lot N102851902 (Exp. 4/30/21);
• 20-count bottles of 150-mg ranitidine tablets (NDC 70934-017-20) from lot D102851801 (Exp. 4/21);
• 24-count bottles of 150-mg ranitidine tablets (NDC 70934-017-24) from lots N102851901 (Exp. 11/30/21), N102851903 (Exp. 12/31/21), and N102851906 (Exp. 3/31/22);
• 30-count bottles of 150-mg ranitidine tablets (NDC 70934-017-30) from lots N102851904 (Exp. 2/28/22) and N102851905 (Exp. 12/31/21);
• 90-count bottles of 150-mg ranitidine tablets (NDC 70934-017-90) from lots C102851901 (Exp. 11/30/21), C102851902 (Exp. 11/30/21), C102851903 (Exp. 11/30/21), C102851904 (Exp. 5/31/21), C102851905 (Exp. 2/28/22), C102851906 (Exp. 2/28/22), and C102851907 (Exp. 3/31/22);
• 15-count bottles of 300-mg ranitidine tablets (NDC 70934-287-15) from lots N106851901 (Exp. 11/30/21) and N106851902 (Exp. 10/31/21); and
• 90-count bottles of 300-mg ranitidine tablets (NDC 70934-287-90) from lots C106851901 (Exp. 11/30/21), C106851902 (Exp. 10/31/21), C106851903 (Exp. 2/28/22), C106851904 (Exp. 11/30/21), and C106851905 (Exp. 5/31/22).

On January 6, 2020, Pharma Pac initiated a voluntary recall of 150-mg ranitidine tablets distributed to physicians in California, Florida, North Carolina, and South Carolina. The tablets were packaged in counts of 7 (NDC 52959-0502-07), 14 (NDC 52959-0502-14), 20 (NDC 52959-0502-20), 30 (NDC 52959-0502-30), and 60 (52959-0502-60) and were from lots RAN63KG (Exp. 5/20), RAN64KG (Exp. 10/20), RAN65KG (Exp. 11/20), and RAN66KG (Exp. 5/21).

On January 7, 2020, Preferred Pharmaceuticals Inc. initiated a voluntary recall of all unexpired ranitidine tablets distributed in Alabama, Arizona, California, Florida, Georgia, Indiana, and South Carolina. The recall includes the following products:

• 30-count bottles of 150-mg ranitidine tablets (NDC 68788-7388-3);
• 60-count bottles of 150-mg ranitidine tablets (NDC 68788-7388-6);
• 90-count bottles of 150-mg ranitidine tablets (NDC 68788-7388-9);
• 100-count bottles of 150-mg ranitidine tablets (NDC 68788-7388-1);
• 14-count bottles of 300-mg ranitidine tablets (NDC 68788-6382-1);
• 30-count bottles of 300-mg ranitidine tablets (NDC: 68788-6382-3);
• 90-count bottles of 300-mg ranitidine tablets (NDC: 68788-6382-9); and
• 100-count bottles of 300-mg ranitidine tablets (NDC: 68788-6382-0).

The FDA designated the recalls Class II on January 20, 2020. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists. 

Prescription ranitidine is used in the treatment of ulcers, gastroesophageal reflux disease, and other conditions that cause excess stomach acid. 

—Jolynn Tumolo